JanOne Selects Partner for Bottling and Labeling of JAN101 for Peripheral Artery Disease and Potential Covid-19 Clinical Trials
Partnership to ensure clinical compliance for active and placebo dosing for PAD phase 2b trials planned for early 2021 and potential trials for treating Covid-19 vascular complications
LAS VEGAS, Aug. 28, 2020 /PRNewswire/ -- JanOne Inc. (Nasdaq: JAN), a company focused on developing treatments for conditions that cause severe pain and drugs with non-addictive, pain-relieving properties, has chosen its bottling and labeling partner to support upcoming clinical trials. JanOne is preparing its investigational new drug (IND) application for FDA submission for JAN101 as a potential treatment for vascular complications caused by Covid-19. JAN101 is already planned for use in Phase 2b trials as a treatment for Peripheral Artery Disease (PAD) expected to start in the first quarter of 2021. JanOne's bottling and labeling partner is a world leader in pharmaceutical testing and will work with the company's clinical and manufacturing teams to ensure the integrity of an initial batch of approximately 3,800 active and placebo bottles of JAN101.
JAN101 is a sodium nitrite based compound that has been shown to improve blood flow, restore vascular function, mitigate inflammation and prevent potential tissue damage in major organs based on results from Phase 1 and Phase 2a studies. There is no current treatment on the market today for PAD and, as there is a growing body of evidence that Covid-19 is a vascular disease, JAN101 has the potential to impact millions of lives.
According to Tony Isaac, JanOne chief executive officer, "Having world-class partners is essential to our success and we continue to build our extended team with some of the most innovative and reputable companies in the world."
JanOne expects to submit the IND for the treatment of Covid-19 vascular complications in the coming weeks. The company continues to advance plans to scale-up production of JAN101 with GMP manufacturing expected to begin by the middle of September. Combining expert formulation and manufacturing with reliable bottling and labeling capabilities, the company believes it can ensure immediate availability of clinical product for its Phase 2b PAD study and for clinical studies as a treatment for Covid-19 vascular complications, pending submission of the IND application and FDA approval.
JanOne (NASDAQ: JAN) is focused on developing treatments for diseases that cause severe pain. By alleviating pain at the source, JanOne aims to reduce the need for opioid prescriptions to treat disease associated pain that can lead to opioid abuse. The company is also exploring solutions for non-addictive pain medications. Its lead candidate JAN101 is for treating peripheral artery disease (PAD), a condition that affects over 8.5 million Americans. JAN101 demonstrated positive results in a Phase 2a clinical trial, and Phase 2b trials are expected to begin in early 2021. JanOne is dedicated to funding resources toward innovation, technology, and education for PAD, associated vascular conditions and neuropathic pain. JanOne continues to operate its legacy businesses under their current brand names, which are undergoing review to determine appropriate strategic alternatives. For more information, visit janone.com
Forward-Looking and Cautionary Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. In accordance with the safe harbor provisions of this Act, statements contained herein that look forward in time that include everything other than historical information, including statements relating to (i) whether JAN101 can treat vascular complications in Covid-19 patients, (ii) whether the company can obtain FDA approval for its Covid-19 study, (iii) when the Phase 2b trials for PAD commence, and (iv) when and whether the company will submit an IND for the treatment of Covid-19 vascular complications, and (v) when manufacturing of JAN101 will commence. These forward-looking statements can be identified by terminology such as "will," "aims," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar statements. JanOne may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the "SEC") on Forms 10-K and 10-Q, Current Reports on Form 8-K, in its annual report to stockholders, in press releases, and other written materials and in oral statements made by its officers, directors or employees to third parties. There can be no assurance that such statements will prove to be accurate and there are a number of important factors that could cause actual results to differ materially from those expressed in any forward-looking statements made by the company, including, but not limited to, plans and objectives of management for future operations or products, the market acceptance or future success of our products, and our future financial performance. The company cautions that these forward-looking statements are further qualified by other factors including, but not limited to, those set forth in the company's Annual Report on Form 10-K for the fiscal year ended December 28, 2019 (available at http://www.sec.gov). JanOne undertakes no obligation to publicly update or revise any statements in this release, whether as a result of new information, future events, or otherwise.
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Released August 28, 2020